Wiping out our ability to sue

By Cory Franklin. Cory Franklin is an emergency room physician at Stroger
Hospital
Published September 17, 2004

Imagine for a minute a corporation manufacturing a product that has the
ability to render everyday items heat resistant. The company produces large
amounts of the compound and incorporates it into routine use so that it
becomes a ubiquitous part of the American household.

But there are clouds on the horizon. Indications arise that, after years of
use, those involved in the manufacture of the compound develop crippling
lung disease and unusual cancers that cause slow, painful death. When
suspicions are confirmed internally, the company makes a fateful
decision--it suppresses the information, concealing it from its own workers
and the public.

For the next 20 years, millions are exposed to the compound until public
health studies reveal the cause and effect. Ultimately the company, which
grew wealthy and powerful on the strength of the compound, must face
thousands of lawsuits and is forced into bankruptcy. In the meantime,
thousands of people have died, exposed to a product originally thought to be
safe.

This, of course, is the 20th Century story of asbestos.

But now imagine a twist in the story that never actually happened. What if,
early on, when it appeared asbestos was a miracle compound, there had been a
Food and Drug Administration? (Much of this occurred before the FDA was
created.) And what if, before most of those cancers and pulmonary problems
had come to light, the FDA--with the backing of the U.S. government, the
primary consumer of asbestos--declared it to be safe? Is it possible the
public would still be facing asbestos exposure today?

It is important to revisit the asbestos story, with the hypothetical FDA
scenario, because if the Bush administration has its way, there will be no
lawsuits and limited public discovery about the dangers of prescription
drugs and medical devices that initially appear safe but ultimately carry
serious long-term dangers. Lawyers for the U.S. Department of Justice
recently argued in court that if the FDA has approved a product, people are
not eligible to recover damages. If a designation of safety by the FDA
provides an absolute defense against lawsuits, the government is essentially
bestowing the Holy Grail on pharmaceutical and medical product companies,
defense lawyers and the insurance industry. No greater gift could come their
way.

Yet the FDA is not now and never can be the ultimate arbiter of product
safety for a very simple reason--it can never see into the future. At best,
the FDA can give only a reasonable indication of a product's current status.
Completely removing the threat of lawsuits leaves the public vulnerable to
all sorts of malfeasance and misfeasance.

Within reason, the government argument has merit. Frivolous litigation does
discourage companies from introducing new products. Companies forced to
contend with different rules in different states face increased costs and
confusion. Clearly, the public is ill-served if new products cannot be made
available because of litigation fears. Venal attorneys and greedy plaintiffs
looking for favorable venues and unjustifiable damages will always be with
us. But all of this simply does not create an imperative for an overly
expansive policy on legal immunity, especially when a government agency,
subject to political winds, has the final word on safety.

If we are meant to understand this new FDA proposal, what Bush officials are
saying, with an absolutely straight face, is this: "I'm here from the
government and I can assure you that the medical product you depend on is
safe. There's no need to worry."

Strange words coming from a Republican administration. And words that not
even the most devoted pro-business, anti-trial lawyer,
medical-innovation-promoting, diehard Chamber-of-Commerce-loving capitalist
could really believe.

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